Safety of Escalating Doses of Intravenous Bone Marrow-Derived Mesenchymal Stem Cells in Patients With a New Ischemic Stroke

Withdrawn

Eligibility Criteria

Inclusion Criteria

- 1. Ischemic stroke in the middle cerebral artery territory, with onset 24-72 hours prior to the time that the therapy transfusion is initiated, radiologically confirmed, and with either diameter >15 mm or volume > 4cc. - 2. The index stroke has clinical deficits that are moderate-severe (NIHSS score 7-20), did not require hemicraniectomy or invasive intracranial pressure monitoring, and was not associated with a concomitant STelevation myocardial infarction. - 3. Age 18-80 years, inclusive - 4. Reasonable likelihood of receiving standard post-stroke medical care, as well as standard physical, occupational, and speech therapy.

Exclusion Criteria

- 1. No substantial pre-stroke disability (pre-stroke modified Rankin Scale score 0-2). - 2. Females of child-bearing potential will be excluded unless (1) a negative urine pregnancy test is obtained and (2) the patient has been effectively using contraceptive method with known failure rate <1 % for at least 90 days. - 3. Lactating mothers - 4. If thrombolytic therapy has been administered, at least 24 hours have passed between completing thrombolytic dosing and initiating the current study's transfusion. - 5. Known allergy to penicillin or to fetal bovine serum - 6. Active co-existent major neurological or psychiatric disease that could significantly interfere with patient compliance or study assessments, including drug or alcohol abuse. - 7. Any diagnosis that makes survival to 1-year post-stroke unlikely. - 8. Participation in any other experimental therapeutic clinical trial concurrently or in the prior three months. - 9. Contraindication to undergoing MRI scanning.

Professionals

Education

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This project is supported in part by the NIH Specialized Programs of Translational Research in Acute Stroke (SPOTRIAS) Network, and NINDS grant 3P50NS055977 to Washington University in St. Louis School of Medicine and UT Southwestern Medical Center.